6. Governance and Ethics

The HREC and RGO submission process for a telehealth trial is similar to that of a traditional trial but involves a few additions. This page outlines the step-to-step process for submission to ethics.

HREC Submission Process

Choose a reviewing HREC and review all relevant requirements and submission deadlines for their meetings.

Agreement from the Sponsor to allow teletrial inclusion,
Inclusion in the ethics section that the trial may be undertaken using telehealth with Satellite Sites,
Copy of the CTN listing the Satellite Sites,
Information about how the patient data will be securely shared between sites,
Participant Information Sheets including optional teletrial specific wording,
If relevant, separate teletrial specific PICFs,
Sponsor agreed process by which consent will be obtained at Satellite Sites,
CV and GCPs for Investigators at each Satellite Site,
Draft or unsigned copy of supervision plan,
HREC’s Form of Indemnity (updated to include Satellite Sites),
If required, radiation assessment report.

In the submission package, it is important that it is clear it is a teletrial study and that the Satellite Sites are supervised by the Primary Site. This needs to be outlined in the approval letter.

The Primary Site must ensure all documentation pertaining to the submission processes is filed in the Site Master File.

Changes to the trial set up must be reported to HREC and an amendment may be needed.

The Primary Site takes responsibility for all reporting to the CPI on behalf of the satellite sites. This includes ongoing reporting to HREC, annual reports and safety reports.

RGO Submission Process

Cover Letter from Primary Site PI
Participant Information Sheets and Consent Forms (with teletrial-specific wording)
CTRA amendment that includes Satellite Sites
Subcontract agreements between Primary Site and Satellite Sites
Signed Supervision Plan between Primary Site and Satellite Sites
Indemnity or insurance cover documented for Satellite Sites.

Cover letter from Satellite Site PI
Site specific Assessment (SSA)
PS RGO authorisation
Cluster participant
Subcontract agreement between PS and SS
Budget signed by SS finance officer
Signed supervision plan between PS and SS
CTRA amendment to add SS.